Chikungunya FeverEarly Phase 1NCT03702348

Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever

A Early Phase 1 study testing Resistance exercise in people with Chikungunya Fever, run by Universidade Federal de Pernambuco at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chikungunya Fever
What is being tested?: Resistance exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteBrazil
Study dates: 23 Jul 2018to Nov 2019
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Chikungunya fever for more than three months
Present musculoskeletal symptoms after infection (eg, arthritis or arthralgia)

Who cannot join

Cognitive deficit that compromises the understanding and accomplishment of the protocol (MiniMental<24);
Self-reported disease that contraindicates the performance of research procedures (eg, unstable angina);
Self-reported diagnosis of neurological disease;
Prior self-reported diagnosis of other inflammatory or autoimmune rheumatic diseases or fibromyalgia;
Pregnancy;
Physical impairment that prevents arrival to the research site or execution of the exercises (eg, use of walking devices);
Execution of other physiotherapeutic treatments during the research period;
Regular practice of physical exercises in other places during the period of participation in the research.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Clínica Escola de Fisioterapia - UFPE
Recife, Pernambuco, 50740-560

Other trials in Brazil

About this study

Official title: Effect of a Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever: Randomized Clinical Trial

Common symptoms of chikungunya fever are persistent arthritis and arthralgia, such symptoms can lead to impairment in functionality. The objective of this study is to evaluate the efficacy of a resistance exercise protocol on the functionality of individuals with chronic musculoskeletal manifestations of Chikungunya fever. Quality of life, number of painful joints, intensity of pain, number of recurrence of exacerbation and thermography are secondary outcomes that will also be evaluated. The protocol uses elastic resistance to strengthen muscle groups that stabilize the main joints affected by Chikungunya Fever. The sessions will be 2 times a week for 12 weeks. The control group will not be submitted to the intervention during the 12 weeks, being contacted through telephone calls. After the reevaluation at the end of the 12 weeks the control group will perform the same protocol. The sample will be characterized and the effect size and the mean difference will be calculated. Intention-to-treat analysis and rate of adherence will also be calculated.

Conditions: Chikungunya Fever
Being tested: Resistance exercise
Medical subject headings: Chikungunya Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Resistance exerciseOther
Also called Resistance exercise protocol
Protocol with 5min warm-up exercise and 8 exercises that progress in positioning and resistance based on maximum repetition test. The exercises strengthen both the lower and upper limbs and are intended to simulate activities such as sitting and standing up, climbing stairs, picking up weight ...

Study groups in NCT03702348
Study group	Role	What they receive
Resistance exercise group	Experimental	Progressive resistance exercise protocol with elastic resistance to strengthen the muscle groups that stabilize the main joints affected by Chikungunya Fever. The sessions will be 2 times a week for 12 weeks. Receives: Other: Resistance exercise
Control group	No intervention	No intervention during the 12 weeks, being contacted through telephone calls. After the reevaluation at the end of the 12 weeks, this group will perform the same protocol as the experimental group

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in functionality through a walk test
Performance in seconds of the 40m Fast-paced Walk Test, the longer the time in seconds, the worse the outcome. The normative values for women between 50´s and 60´s age range are 19,90 to 22,60 seconds, and for men in the same age range between 19,32 and 20,73 seconds.
Measured: Assessed before intervention, in 6 weeks and after the 12-week intervention
Change in functionality through a stair climb test
Performance in seconds of the 4 step stair climb test, the longer the time in seconds, the worse the outcome. The normative values mean for healthy women is 10.22 seconds and healthy men is 8.72 seconds
Measured: Assessed before intervention, in 6 weeks and after the 12-week intervention
Change in functionality through a chair stand test
Performance in number of time the patient stands in the 30-Second Chair Stand Test, the higher the number of the better the outcome, the mean for women in the 60´s age range is from 11 to 17 times and for men in the same age range is from 12 to 19 times
Measured: Assessed before intervention, in 6 weeks and after the 12-week intervention
Change in functionality of upper limbs
Function of upper limb trough specific score of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire with 30 items with responses range from 1(not limited) to 5 (extremely limited) and two optional sections, responses are used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)
Measured: Assessed before intervention, in 6 weeks and after the 12-week intervention

Secondary outcomes (8)

Change of score on the Medical Outcomes Study 36 - Item Short - Form Health Survey questionnaire
quality of life assesment through Medical Outcomes Study 36 - Item Short - Form Health Survey questionnaire that consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0 (maximum disability) to 100(no disability) scale
Measured: assessed before intervention, in 6 weeks and after the 12-week intervention
Change in the intensity of pain: VAS
number correspondent to the intensity of pain using visual analogic scale from 0(no pain) to 10 (maximum pain)
Measured: assessed in every intervention day (twice a week for 12 weeks)
Change in the number of painful joints
assessed though a tender joints count, the higher the number the worse the outcome
Measured: assessed before intervention, in 6 weeks and after the 12-week intervention
Change in the number of exacerbation recurrences
the higher the number the worse the outcome
Measured: assessed through the 12-week intervention period
Change in temperature of areas of interest (joints)
assessed with thermography through index of thermic distribution seen through software FLIR Tools 5.3. the higher the temperature the worse the outcome
Measured: assessed before intervention, in 6 weeks and after the 12-week intervention
Change in patients global impression of change
number corresponding to answer of the Patient Global Impression of Change (PGIC) questionnaire being 1 (no change) the worst outcome and 7 (a lot better) the best outcome
Measured: assessed before intervention, in 6 weeks and after the 12-week intervention
Number of patients reporting adverse effects
Unexpected effects reported by patients potentially associated with the intervention such as worsening pain, swelling, stiffness or other
Measured: Reported through study completion, an average of 1 year
Change in muscle strength
Performance in the repetition maximum test (1RM) for every exercise, the higher the value the better the outcome
Measured: Assessed every two weeks during the 12-week intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 2018Nov 2019

First posted11 Oct 2018
Study start23 Jul 2018
Primary completionOct 2019 (estimated)
Study completionNov 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chikungunya FeverStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03702348
Sponsor's protocol ID: U1111-1216-9761
Status last verified: Sep 2019
First submitted: 9 Jul 2018
Last updated: 27 Sep 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chikungunya Fever trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever: Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03702348
Acronym / sponsor ID: U1111-1216-9761
Conditions: Chikungunya Fever
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Universidade Federal de PernambucoUniversity, hospital or other
Study start: 23 Jul 2018 (actual)
Primary completion: Oct 2019 (estimated)
Study completion: Nov 2019 (estimated)
First posted: 11 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Resistance exercise group	Experimental	Other: Resistance exerciseProgressive resistance exercise protocol with elastic resistance to strengthen the muscle groups that stabilize the main joints affected by Chikungunya Fever. The sessions will be 2 times a week for 12 weeks.
Control group	No intervention	–No intervention during the 12 weeks, being contacted through telephone calls. After the reevaluation at the end of the 12 weeks, this group will perform the same protocol as the experimental group

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of Chikungunya fever for more than three months
Present musculoskeletal symptoms after infection (eg, arthritis or arthralgia)

Key exclusion criteria (8 listed)

Cognitive deficit that compromises the understanding and accomplishment of the protocol (MiniMental<24);
Self-reported disease that contraindicates the performance of research procedures (eg, unstable angina);
Self-reported diagnosis of neurological disease;
Prior self-reported diagnosis of other inflammatory or autoimmune rheumatic diseases or fibromyalgia;
Pregnancy;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Resistance exerciseAlso: Resistance exercise protocolProtocol with 5min warm-up exercise and 8 exercises that progress in positioning and resistance based on maximum repetition test. The exercises strengthen both the lower and upper limbs and are intended to simulate activities such as sitting and standing up, climbing stairs, picking up weight ...	Other	Resistance exercise group

Primary outcome

Change in functionality through a walk test
Time frame: Assessed before intervention, in 6 weeks and after the 12-week intervention
Performance in seconds of the 40m Fast-paced Walk Test, the longer the time in seconds, the worse the outcome. The normative values for women between 50´s and 60´s age range are 19,90 to 22,60 seconds, and for men in the same age range between 19,32 and 20,73 seconds.
Change in functionality through a stair climb test
Time frame: Assessed before intervention, in 6 weeks and after the 12-week intervention
Performance in seconds of the 4 step stair climb test, the longer the time in seconds, the worse the outcome. The normative values mean for healthy women is 10.22 seconds and healthy men is 8.72 seconds
Change in functionality through a chair stand test
Time frame: Assessed before intervention, in 6 weeks and after the 12-week intervention
Performance in number of time the patient stands in the 30-Second Chair Stand Test, the higher the number of the better the outcome, the mean for women in the 60´s age range is from 11 to 17 times and for men in the same age range is from 12 to 19 times
Change in functionality of upper limbs
Time frame: Assessed before intervention, in 6 weeks and after the 12-week intervention
Function of upper limb trough specific score of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire with 30 items with responses range from 1(not limited) to 5 (extremely limited) and two optional sections, responses are used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)

8 secondary outcomes

Change of score on the Medical Outcomes Study 36 - Item Short - Form Health Survey questionnaire
Time frame: assessed before intervention, in 6 weeks and after the 12-week intervention
Change in the intensity of pain: VAS
Time frame: assessed in every intervention day (twice a week for 12 weeks)
Change in the number of painful joints
Time frame: assessed before intervention, in 6 weeks and after the 12-week intervention
Change in the number of exacerbation recurrences
Time frame: assessed through the 12-week intervention period
Change in temperature of areas of interest (joints)
Time frame: assessed before intervention, in 6 weeks and after the 12-week intervention
Change in patients global impression of change
Time frame: assessed before intervention, in 6 weeks and after the 12-week intervention
Number of patients reporting adverse effects
Time frame: Reported through study completion, an average of 1 year
Change in muscle strength
Time frame: Assessed every two weeks during the 12-week intervention period

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.

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RecruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Resistance exercise in people with Chikungunya Fever, run by Universidade Federal de Pernambuco at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in functionality through a walk test (time frame: Assessed before intervention, in 6 weeks and after the 12-week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03702348.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.